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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Incubator, Neonatal Transport
510(k) Number K031096
Device Name MODIFICATION TO TRANSPORT INCUBATOR 185
Applicant
INTERNATIONAL BIOMEDICS, INC.
8508 CROSS PARK DR.
AUSTIN,  TX  78754
Applicant Contact GERALD MANNING
Correspondent
INTERNATIONAL BIOMEDICS, INC.
8508 CROSS PARK DR.
AUSTIN,  TX  78754
Correspondent Contact GERALD MANNING
Regulation Number880.5410
Classification Product Code
FPL  
Date Received04/07/2003
Decision Date 06/24/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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